Patient Enrollment Completed for Phase III Clinical Trial of Boan Biotech’s Dulaglutide Injection BA5101 in China

Yantai, May 15, 2023 – Boan Biotech today announced the completion of patient enrollment for the Phase III clinical trial (a comparative clinical study of efficacy and safety) of the company’s Dulaglutide Injection (BA5101) in China.

BA5101 is a biosimilar of Trulicity^®, used for glycemic control in adults with insufficiently controlled type 2 diabetes mellitus. The Phase III clinical trial is a randomized, open-label, parallel group and positive-controlled clinical study that compares the clinical efficacy and safety of BA5101 with Trulicity in Chinese adult patients with type 2 diabetes. It will further compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of BA5101 with Trulicity after multiple subcutaneous injections in these patients.

Dulaglutide has multiple clinical advantages, but developing a biosimilar of it is difficult

Dulaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist administered once a week. Compared with other glucose-reducing drugs, Dulaglutide can improve the functions of β-cells, stably and effectively reduce blood glucose and HbA1c levels. In addition, due to its unique mechanism of action, Dulaglutide can simultaneously improve multiple risk factors for cardiovascular diseases such as weight gain, hyperlipidemia/blood lipids and long-term cardiovascular disease risks, and is not prone to causing lower hypoglycemia rate. It also has a protective effect on the kidney¹. Moreover, several clinical studies have shown that patients taking Dulaglutide once a week have higher compliance because of the convenience of use.

The development of BA5101 follows the guidelines for biosimilar in China, the U.S., Europe and other countries and regions. The preclinical comparative studies show that BA5101 is highly similar to Trulicity in terms of physicochemical properties and biological activities. As a fusion protein, the development of Dulaglutide biosimilar is difficult in terms of CMC. Boan Biotech has overcome the technical problems such as oxidation, truncation and complex charge heterogeneity of Dulaglutide. The results of the completed Phase I clinical trial in China show that BA5101 has highly similar PK characteristics, safety and immunogenicity with Trulicity, indicating that it has clinical similarity with the reference product. The clinical results have been published in the journal of Expert Opinion on Biological Therapy, Taylor & Francis².

The situation of diabetes is severe with the number of patients constantly growing around the world

Nowadays, the situation of diabetes is severe in China and even around the world. According to the latest data from the International Diabetes Federation (IDF), in 2021, there were about 537 million diabetic patients (age 20-79) worldwide, and this number is expected to grow to 643 million and 784 million by 2030 and 2045 respectively. In 2021, China had around 141 million diabetic patients (age 20-79), and this number is expected to grow to 164 million and 174 million by 2030 and 2045 respectively³.

Given the huge unmet needs of diabetic patients, Boan Biotech believes that BA5101 will have a promising market around the world. According to publicly available data, the global sales of Trulicity were USD 7.44 billion in 2022, growing 15% from 2021.

Dr. Dou Changlin, President of R&D and Chief Operating Officer of Boan Biotech, said: “As far as we know, BA5101 is the world's first Phase III clinical trial of a Dulaglutide biosimilar, and is expected to be the first biosimilar of Trulicity to be commercialized. Dulaglutide has a wide range of clinical needs, and it is expected to provide high quality and affordable biological drugs for type 2 diabetes patients in China after its launch. At the same time, Boan Biotech has started work regarding overseas clinical trials and registration for BA5101, in order to further expand its international business.”

References:

1. Hertel C Cerstein, Helen M Colhoun, Gilles R Dagenais, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial [J]. Lancet. https://doi.org/10.1016/S0140-6736(19)31149-3
2. Qin Zhang, Cheng Sun, Jinying Wu, et al. Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects [J]. Expert Opinion on Biological Therapy. https://doi.org/10.1080/14712598.2023.2189009
3. International Diabetes Federation. https://diabetesatlas.org/.Accessed on May 15, 2023

(Note: the previous product number of BA5101 is LY05008)